Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

With CDMOs Like This, Who Needs Biotechs?

The question struck like a thunderbolt, writes Chief Editor Louis Garguilo. “Where are CDMOs going with all this?” asked Edward Ahn, CEO, Medipost, Inc., referring to the remarkable growth of some CDMOs. “When CDMOs aim to offer every service, capability, and the requisite capacities for an entire drug life cycle – from discovery to clinic to commercialization – what’s actually left for a biotech sponsor to do?” A forward discussion on an evolving outsourcing dynamic.

GUEST COLUMNISTS

New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
Facility Considerations When Retrofitting Legacy Sites For ADCs
Antibody-drug conjugate manufacturing requires, among other things, unidirectional flow and air locks for people and materials. Facilities often lack these attributes.
In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
Managing Supply Chain Risk In Scale-Up And Multisite Trials
Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.
The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
Why Use Total Organic Carbon Analysis For Cleaning Validation?
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
Global Clinical Supply — Confronting Persistent Challenges With Strategic Action
From regulatory fragmentation to cold chain risks, discover how strategic action, data visibility, and resilient design keep clinical trials on track.
December 2025 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

PHARMA OUTSOURCING WHITE PAPERS

Advanced Methodology Of PLGA-Based Parenteral Formulations
To enable the development of optimized PLGA-based sustained release formulations, this paper offers essential insights into the polymer’s properties, fabrication techniques, and drug release mechanisms.

Leveraging Flow Chemistry
Discover how continuous processing cuts waste, improves efficiency, and supports safer, scalable reactions while helping teams meet sustainability goals and speed development.
Maximizing rAAV Production Efficiency: Introducing Pro10™ Cell Line
This HEK293-derived, animal component-free suspension cell line forms the foundation of a scalable, robust platform process that accelerates AAV manufacturing.
Nose To Brain (N2B) Drug Delivery – Benefits And Challenges
Delve into the growing interest in drug delivery methods that target the brain and central nervous system via absorption into the bloodstream, specifically focusing on crossing the blood-brain barrier (BBB).
Innovation In Filtration
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
SMB Technology: Optimizing API Purification
Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.